β¨ Health and Environmental Notices
5 SEPTEMBER 2013 NEW ZEALAND GAZETTE, No. 124 3453
Photocopying of incorporated material will not be permitted.
Purchase of Material
Material may be purchased directly from:
Standards New Zealand
Level 6
8 Gilmer Terrace
Wellington 6011.
By post: Private Bag 2439, Wellington 6140.
Website (for online purchases): www.standards.co.nz
Telephone (for ordering by freephone): 0800 782 632.
Email (for ordering by email): enquiries@standards.co.nz
Materials may be ordered from Standards New Zealand by using a telephone available free of charge at the Ministry offices listed above.
Dated this 22nd day of August 2013.
CRAIG MALLETT, Manager, Environmental Risk and Innovation, Ministry for the Environment (acting under delegated authority).
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Health
Medicines Act 1981
Consent to the Distribution of a New Medicine
Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Gaviscon Pregnancy
Active Ingredients: Potassium bicarbonate 20mg/mL
Sodium alginate 100mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Yorkshire, United Kingdom
Dated this 28th day of August 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).
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Classification of Medicines
Pursuant to section 106(1) of the Medicines Act 1981, I, Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health, acting under delegated authority, hereby declare that the medicines listed in Schedule 1 to this notice are classified as prescription medicines.
Every reference to a medicine in this notice applies whether the medicine is synthetic in origin or is from biological or mineral sources.
Unless specific reference is made otherwise, every reference applies also to medicines that are:
(a) preparations and admixtures containing any proportion of any substance listed in the notice.
(b) salts and esters of any substance listed in the notice.
(c) preparations or extracts of biological materials listed in the notice.
(d) salts or oxides of elements listed in the notice.
Unless specific reference is made otherwise, every reference to a medicine applies:
(i) if the medicine is in an injection or eye preparation, to any concentration of that medicine; and
(ii) if the medicine is not in an injection or eye preparation, only if the concentration of the medicine is greater than 10 milligrams per litre or per kilogram.
Where any reference is modified by a statement of the strength of the medicine, the strength is calculated using the free acid, base, alcohol or element unless specifically stated otherwise.
Schedule 1
Prescription Medicines
Alogliptin
Crofelemer
Dimethyl fumarate
Fidaxomicin
Glycopyrronium
Ivacaftor
Micafungin
Olodaterol
Pasireotide
Pasireotide diaspartate
Retapamulin
Retigabine
Ridaforolimus
Vismodegib
Dated this 27th day of August 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health.
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β¨ LLM interpretation of page content
π₯
Material Incorporated by Reference in Hazardous Substances Regulations
(continued from previous page)
π₯ Health & Social Welfare22 August 2013
Hazardous Substances, Regulations, Incorporated Material, Safety Standards
- Craig Mallett, Manager, Environmental Risk and Innovation, Ministry for the Environment
π₯ Consent to the Distribution of a New Medicine
π₯ Health & Social Welfare28 August 2013
Medicines Act, New Medicine, Gaviscon Pregnancy, Reckitt Benckiser
- Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
π₯ Classification of Medicines
π₯ Health & Social Welfare27 August 2013
Medicines Act, Prescription Medicines, Classification, Health Regulations
- Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
NZ Gazette 2013, No 124